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ABSTRACT
Promethazine is an anti-histamine used in cases of nausea, vomiting, motion sickness etc. The study is to examine the in-vitro quality parameters of eight brands of promethazine hydrochloride tablets sold in retail pharmacies in Edo State, of Nigeria.
The parameters determined were weight variation, friability, hardness, disintegration, and assay (active content uniformity). All samples were evaluated for conformity with British Pharmacopoeia (BP) standards. The results obtained showed tablet weight ranging from 0.0836g ± 0.006 to 0.2803 ± 0.005, hardness from 2.86 ± 0.47 to 6.38 ± 0.57 kg/cm2, friability of < 1.07 %, disintegration time of 0.23 ± 0.08 to 27.42 ± 0.77 min and assay of 87.66 % to 98.14 %. The active drug content/drug assay results for brand B (88.82 %w/w) and brand C (87.66% w/w) showed that they did not meet the USP specification for Promethazine (90.0 -110.0 % of the labeled content) using the USP non-aqueous titration method. The results showed that not all samples examined passed all the pharmacopoeial tests for satisfactory quality. Thus, they all cannot be used interchangeably in clinical practice. To conduct post-marketing assessment of the quality of these medicines to ascertain whether they meet pharmacopoeial standards or not, represents a huge step in determining the extent to which the quality of essential medicines is implicated in contributing to health challenges in the country, and in the world at large.
